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Last Updated: March 21, 2023

Regulatory Exclusivity Expiring in 2022

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Drugs with Regulatory Exclusivity Expiring in 2022

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No	See Plans and Pricing	MAINTENANCE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	See Plans and Pricing	MAINTENANCE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
Gland Pharma Ltd	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216249-001	May 3, 2022	AP	RX	No	No	See Plans and Pricing	COMPETITIVE GENERIC THERAPY
Gland Pharma Ltd	ZINC SULFATE	zinc sulfate	SOLUTION;INTRAVENOUS	216249-002	May 3, 2022	AP	RX	No	No	See Plans and Pricing	COMPETITIVE GENERIC THERAPY
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	See Plans and Pricing	NEW CHEMICAL ENTITY
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes	See Plans and Pricing	NEW CHEMICAL ENTITY
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	See Plans and Pricing	NEW CHEMICAL ENTITY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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